The purpose of this study is to test the safety of different dose strengths of INX-08189 in healthy adults. The study will also look at how rapidly the drug breaks down in the body (pharmacokinetics or PK). The study objectives include:

To evaluate the safety of single ascending oral doses of INX-08189 in healthy subjects

To characterize the pharmacokinetic (PK) profile of single ascending oral doses of INX-08189 in healthy subjects

To assess the food effect on the PK of a single oral dose of INX-08189

A Study of the Safety and Pharmacokinetics of Single Ascending Oral Doses of INX-08189 in Healthy Subjects

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Evaluate the safety of single ascending oral doses of INX-08189 in healthy subjects [ Time Frame: periodically over 14 days ] [ Designated as safety issue: Yes ]

Safety will be evaluated on the basis of adverse event (AE) incidence, changes in serum chemistry and hematology values, urinalysis results, and changes in vital signs and in electrocardiogram (ECG) findings.

Characterize the pharmacokinetic (PK) profile of single ascending oral doses of INX-08189 in healthy subjects [ Time Frame: periodically over 14 days ] [ Designated as safety issue: Yes ]

Including a determination of maximum observed plasma concentration (Cmax), time at which the maximum plasma concentration was observed (Tmax), time at which concentrations are first measurable in the plasma (Tlag), area under the plasma concentration-time curve from time 0 to time of last measurable plasma concentration (AUC 0-last) and elimination half-life (T 1/2) after single ascending oral doses.

Assess the effect of a high fat meal on the PK parameters [ Time Frame: periodically over 14 days ] [ Designated as safety issue: Yes ]

The effect of food (standard high-fat meal) on the absorption of INX-08189 will be evaluated

Regular use of medications, prescription or non-prescription; no medication may be taken within 1 week prior to study dosing

Use of alcohol within 48 hours prior to dosing (subjects must also agree to not use alcohol for 96 hours after dosing)

Current lactation or breastfeeding

Major surgery within 30 days prior to dosing

Receipt of an investigational drug within 30 days prior to dosing

Donation of blood or plasma within 30 days prior to dosing

Any other problem, that in the opinion of the Investigator, will affect the safety of the subject or outcome of the study

Contacts and Locations

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159808